Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery

NCT03624257 | Withdrawn

• 2 other identifiers: Peri-implantitis 445 nm laserCIV-1 8-06-024304
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

Conditions

Peri-Implantitis

Keywords

Laser treatment; surgical treatment; patient reported outcomes; microbiology; immunology; radiological examination

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.

  Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.

  At baseline and 6 months post treatment

Secondary Outcomes (9)

• Mean change from baseline in Plaque index (PI) at 6 months after treatment.

  At baseline and 6 months post treatment

• Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.

  At baseline and 6 months post treatment

• Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.

  At baseline and 6 months post treatment

• Mean change from baseline in Presence of suppuration at 6 months after treatment.

  At baseline and 6 months post treatment

• Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.

  At baseline and 6 months post treatment

Study Arms (2)

Scaling and root planning + Laser treatment

EXPERIMENTAL

Device: Laser treatment

Mucosal flap surgery

ACTIVE COMPARATOR

Procedure: Mucosal flap surgery

Interventions

Laser treatment DEVICE

The participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.

Scaling and root planning + Laser treatment

Mucosal flap surgery PROCEDURE

The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.

Mucosal flap surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of pocket probing depth (PPD) \> 5 mm
• Bleeding on probing/suppuration (BOP/Pus)
• At least 2 mm loss of bone, visible on radiographs, after initial osseointegration.
• ≥ 18 years old.
• Patient able to understand Swedish.

You may not qualify if:

• Antibiotic treatment 6 months prior to baseline.
• Peri-implant treatment 6 months prior to baseline.
• Myocardial infarction 6 months prior to baseline.
• Previous radiation treatment in the affected jaw area.
• Previous i.v. bisphosphonate treatment.
• Moderate or severe impairment of cognitive function (e.g. dementia).

Sponsors & Collaborators

• Sirona Dental Systems GmbH: lead

Study Sites (2)

Danakliniken Specialist Dentistry, Mörby Centrum floor 5

Danderyd, 18231, Sweden

Location

Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet

Huddinge, 14152, Sweden

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Annsofi Johannsen

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking for the assessors of microbial, immunological and radiographic analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Dental Hygienist (RDH); Associate professor

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)